Documenting Medical Device Implants - Pilot Success
GS1 Ireland led an international coalition which successfully employed a sterile field scanner during surgery. The "TRACTUS" scanner by Matrix IT Medical Tracking Systems effectively collected detailed medical device information from extremely small codes known as data matrix codes on hospital-sterilized implants at Wheeling Hospital in West Virginia, USA. For the first time, full medical device traceability was proven on these implants, allowing for future device analytics.
GS1 accredited as issuing agency for UDI by FDA
Based on the UDI rule released in September 2013, the U.S. Food and Drug Administration (FDA) has officially accredited GS1® as a Unique Device Identifier (UDI) issuing agency. (Brussels, Belgium, 17 December 2013).